BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT VERIO PRO METER

    MDR report key: 2230022 · Received August 31, 2011

    Report

    Report Number
    3008382007-2011-00288
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Report Date
    August 1, 2011
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED LIFESCAN (B)(4) ALLEGING THAT THE SUBJECT METER READ LOWER COMPARED TO ANOTHER METER. THE PATIENT OBTAINED "6.0 MMOL/L" WITH THE SUBJECT METER AND "10.0 MMOL/L" WITH ANOTHER METER WITHIN AN UNSPECIFIED TIME. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS LIFESCAN'S CRITERIA FOR ACCURACY. THE REPORTED ISSUE WAS NOT RESOLVED WITH CUSTOMER SERVICE TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT VERIO PRO METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR